Structured Data Capture (SDC) Initiative

Overview for the S.M.A.R.T. Informatics Think Tank

Evelyn Gallego-Haag, MBA, CPHIMSInitiative Coordinatorevelyn.gallego@siframework.org

Title

• Introduction• Background• Standards Overview: Phase 1 & Phase 2 Implementation

Guidance• SDC Data Element Framework• SDC Pilot Program

2

SDC Background

• Launched in 2013 in collaboration with other Federal Partners: NIH (NLM, NCI), AHRQ, FDA, CMS & CDC

• Key area of focus is enabling the collection of structured data within EHRs to supplement data collected for other purposes to include: • Clinical research (Patient Centered Outcomes Research/

Comparative Effectiveness Research) (NLM FOCUS)• Patient safety event reporting (AHRQ FOCUS) & Adverse

Event Reporting (FDA FOCUS)• Public Health Reporting (CDC FOCUS)• Determination of Coverage (CMS FOCUS)

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SDC Standards Focus

SDC Initiative has identified four areas that specify how EHR systems can capture and store structured data:1. Standard for the structure/definition of the CDEs that will be

used to fill the specified forms or templates2. Standard for the structure or design of the form (container)3. Standard for how EHRs interact with the form or template4. Guidance to pre-populate and auto-populate form or template

with existing patient data

4

4

1

5

Sends requested form/template

Fills, stores/transmits structured data

Sends request for form/template

3 Converts, populates & displays form

Extract, Transform,& Load Data by form/ template

Forms Manager

Forms Filler

Actor Key

Structured Data Capture Conceptual Workflow

2

xx

John Doe x

x x

x x

External Repository

SDC

Scop

e

SDC Solution Plan:In Scope Transactions

SDC Solution Plan presented in terms of 3 Transactions:• Transaction 1A: Form/Template Request and Response

without Patient data• EHR System sends request for blank form/template to Form/Template

Repository • Form/template Repository sends requested blank form to EHR System

• Transaction 1B: Form/Template Request and Response with Patient data• EHR System sends request for form/template with relevant patient data

to Form/Template Repository• Form/Template Repository sends form/template with pre-populated

patient data to EHR system

• Transaction 1C: EHR System sends completed form/template to External Data Repository

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Phase 1 Solution: SDC IHE Profile

• SDC standards identified for Phase 1 are not ‘new’; most are mature standards being used across industry to meet specific interoperability specifications

• SDC Standards are specified via:• SDC IHE Profile: Published in Sept 2014

http://ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_SDC.pdf ; tested at January 2015 IHE North American Connectathon

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Content & Structure

• CDA• ISO/IEC 11179• ISO/IEC 19763-13

Transport, Security, and Authentication

• IHE RFD• IHE ATNA• SOAP• TLS v1.0 or higher• SAML

SDC IHE Profile Testing: IHE NA Connectathon 2015 Participants

IHE Profile Role Description Organization Name

Form Filler Retrieves forms from a Form Manager as and when required. When requesting a form, the Form Filler can optionally provider EHR context information by providing pre-population xml data in the request for use by the Form Manager.

EpicmTuitive, Inc.NHDSGE

Form Manager Supplies forms to Form Fillers based upon form retrieval requests. In some cases, may return a form whereas in other cases the returned form may be selected or constructed based upon context information supplied in the form retrieval request.

JBS InternationalNational Cancer Institute (NCI)DCG, Inc. (USHIK)Aegis.Net

Form Receiver Receives and processes completed or partially completed forms instance data from a Form Filler.

CDCFDACRG MedicalCDPHJBS International

Form Processor Performs combined role of both Form Manager and Form Receiver

JBS International

SDC Compliant Forms Tested

1. eCC-Adrenal (CAP)2. Adverse Events (Patient Safety) (AHRQ)3. MedWatch 3500 (Adverse Event Report) (FDA)4. Demographics (Clinical Trials) (NCI)5. Demographics for pre-population (use of PRPH-CA

CDA R2 example)

Phase 2 Solution: SDC HL7 FHIR Profile

• Kicked-off in March 2014; intent was to build on emerging ‘content’ standard FHIR and REST interactions

• Scope is to define HL7 FHIR CommonDataElement Resource that utilizes ISO/IEC 11179-3 syntax with core attributes to facilitate the definition of common data elements

• Also includes development of a mechanism for clinical systems to expose CDEs for research use leveraging existing FHIR Questionnaire Resource

• HL7 SDC FHIR Profile Implementation Guide published as ‘draft for comment’ in Aug 2014: http://hl7.org/implement/standards/FHIR-Develop/sdc.html– Received 165 votes (75 Affirmative, 35 Negative, 55 Abstain)– Currently in ballot reconciliation phase– HL7 FHIR IG will be balloted as DSTU in April 2015; expected publication

date is August 2015

SDC FHIR Implementation Guide:Representation of SDC DE Model

SDC DataElementProfile

SDC Questionnaire Profile

SDC Questionnaire Answers Profile

SDC ValueSet Profile

DataElement

Questionnaire

QuestionnaireAnswers

ValueSet

REST

SDC Security Consideration

Provide constraints and extensions for each

Resource

SDC FHIR Data Element Profile serves as the Logical Model

Data Set(grouping)

Data Element(semantics)

Data Element Attribute(syntax)

Vitals ProblemsLab

Results

Medications

Systolic BP

Diastolic BP

Common DE

DE Concept

Value Domain

SDC Data Element Definition Framework

Allergies

Height

Set of characteristics that describe DE and help define, use and maintain DE using ISO1179-

3 syntax

Logical groupings of data elements

Unit of data for which the definition, identification,

representation, and permissible values are

specified by means of sets of attributes.

Common Data Elements (CDEs) are those DEs that are developed, maintained and used based on commonly agreed upon principles by the user community. CDEs are reusable across a variety of clinical and non-clinical domains.

MU2 Data Set

SDC PSE/AE Pilot ProgramSDC Pilot Program: Test & Validation of SDC

Standards

SDC Content Workstreams

• Established to validate, test and pilot the SDC Solution Standards• Three Workstreams:

• Public Health Tiger Team • Established in Summer 2013• Piloted SDC IHE Profile for Cancer Reporting

• Patient Safety Event Reporting & Adverse event Reporting Sub-Workgroup

• Established in Feb. 2014• Piloted SDC IHE Profile for adverse event reporting from

EHRs to AHRQ and FDA• PCOR Sub-Workgroup

• Proposed start Summer 2015; focus on clinical research

Aim for Pilot Program

• Bring awareness on available national standards that will facilitate how non-clinical data like patient safety and public health data is collected and reported by EHR systems

• Identify additional content and workflow requirements for reporting

• Provide tools and guidance for managing and evaluating SDC Pilot Projects

• Create a forum to share lessons learned and best practices

• Real world evaluation of SDC IHE Profile & FHIR Profile– Is this implementable? Useable?

• Harmonize ‘content’ data elements and forms

Why Pilot SDC Standards?

• Demonstrate compliance with Federal Reporting Requirements

• Increase efficiency of development and maintenance of SDC standards

• Advance National Learning Health System (LHS) where patient information can flow securely from EHRs to other systems

• Validate criteria for inclusion in ONC EHR Certification Program and ONC Standards Advisory

• Reduce data collection burden on health care providers• Improve comparability of data to better inform research,

quality reporting and ultimately, influence patient care• Contribute to the Medical Device community• Be recognized as an early adopter

SDC Leads Contact Information

• Initiative Coordinator: Evelyn Gallego (evelyn.gallego@siframework.org)• Federal Lead: Farrah Darbouze (farrah.darbouze@hhs.gov) • Project Manager: Jenny Brush (jenny.brush@esacinc.com)• CDE SME: Mark Roche (mrochemd@gmail.com) • Harmonization/Technical Lead: Vijay Shah (vshah@jbsinternational.com)• Standards Development Support: Perri Smith (perri.smith@accenture.com)

SDC Wiki Page: http://wiki.siframework.org/Structured+Data+Capture+Initiative

Weekly All-Hands Meeting Info (Thursdays):• Time: 3:25pm – 4:30Ppm Eastern• URL: https://siframework1.webex.com/• Dial-In Number: 1-650-479-3208• Access Code: 663 397 496

Thank you!